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New treatment option for High-Risk Neuroblastoma
Official title Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease
ClinicalTrials.gov ID: NCT05272371
What this study is testing
What is Chemoimmunotherapy (Dinutuximab beta in combination with chemotherapy)?
Chemoimmunotherapy (Dinutuximab beta in combination with chemotherapy) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high-risk neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Safety evaluation and initial efficacy evaluation will be conducted in a group of patients as a non-commercial, open-label clinical trial of dinutuximab beta (Qarziba) phase IIa. The investigational medicinal product will be dinutuximab beta (anti-GD2 antibodies against GD2 disialoganglioside on NBL cells) at a dose of 10 mg / m2 / day by continuous infusion for 5 days in combination with irinotecan / temozolomide, topotecan / temozolomide or N5 / N6 chemotherapy GPOH protocol.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).
- Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.
- Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in...
You likely can't join if
- Life expectancy ≥6 months.
- Obtaining the informed written consent of the patient and/or statutory representative for the treatment.
- Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination...
- Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study. Exclusion Criteria:
- Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
- Patients with neurological toxicities of ≥2 CTCAE WHO grade.
See the full eligibility criteria
- Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).
- Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.
- Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the
- Life expectancy ≥6 months.
- Obtaining the informed written consent of the patient and/or statutory representative for the treatment.
- Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding.
- Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study. Exclusion Criteria:
- Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
- Patients with neurological toxicities of ≥2 CTCAE WHO grade.
- Active life-threatening infection until stabilization of the patient's condition.
- Pregnancy and / or lactation.
- Sexually active patients who refuse to use an effective method of contraception.
- Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study.
- Radiotherapy within 3 weeks prior to the start of the study.
- Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL).
- Lack of informed written consent to treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Krakow, Malopolska, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Krakow, Malopolska, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.